MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MONOJECT VIAL ACCESS CANNULA; CANNULA, SURGICAL, GENERAL PLASTIC SURGERY

Model Number 8881540133

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

When rn was drawing up medication from vial to syringe, the vial access cannula had a small hole in the side and medication was squirting out of it.Resulting in wasted medication.Vial and medication had to be wasted and a new vial was utilized.

• Brand Name: MONOJECT VIAL ACCESS CANNULA
• Type of Device: CANNULA, SURGICAL, GENERAL PLASTIC SURGERY
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 11588278
• MDR Text Key: 242992969
• Report Number: 11588278
• Device Sequence Number: 1
• Product Code: GEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881540133
• Device Catalogue Number: 8881540133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2021
• Event Location: Other
• Date Report to Manufacturer: 03/30/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1